The ClinReg team is composed of experts from a range of disciplines, ensuring that our clients benefit from our remarkable depth of regulatory experience and clinical understanding.
Judy F. Gordon, DVM, founder and president of ClinReg Consulting Services, has over 25 years progressive clinical, regulatory, quality and R&D experience in the pharmaceutical and medical device industry. Accomplishments include:
Dr. Gordon has served as the industry representative to FDA Medical Devices Dispute Resolution Advisory Panel and the Ophthalmic Devices Advisory Panel to FDA.
Robert Lee Kramm, MD, MSE is a Board-certified ophthalmologist and regulatory professional with 5 years of experience as a medical officer and senior reviewer at the Division of Ophthalmic, Neurological and ENT Devices (DONED) at FDA and an additional 5+ years of consulting as a senior regulatory consultant for devices, biologics, and drug products at ClinReg Consulting Services. Dr. Kramm has reviewed and prepared regulatory opinion memos, de novo applications, clinical trial plans, pre-submissions, IDEs, PMAs, 510(k)s, Humanitarian Use Designations (HUDs), requests for designation (RFD) and has been the lead for ClinReg’s device regulatory activities with consistently successful outcomes.
Yi Jing Duh, PhD has over 30 years of experience as a senior statistician and head of statistical services in the medical devices and pharmaceutical industry. She has overseen the statistical planning for over 50 clinical studies, from study design, sample size calculations, and analysis plans to CRF development, database design, development and validation, SAS programming and output, and presentation to regulatory agencies in support of PMA and NDA applications. She has collaborated with both large and small start-up companies in ophthalmic, cardiovascular, urology, respiratory, and oncology studies. Yi-Jing has been directly involved in PMA, 510(k) and NDA approvals for over 35 medical devices and pharmaceuticals in the U.S., EU, and Japan, has interfaced extensively with FDA clinical and statistical reviewers, and has participated in FDA panel preparations.
Gerry Gray, PhD is a highly accomplished statistician with 20 years at FDA, starting as a mathematical statistician at CDRH then moving up to Team Leader for Cardiovascular and Ophthalmic Devices, followed by Associate Director, Division of Biostatistics and, in his last position at FDA, serving as Deputy Director of Biostatistics for CDRH. During Dr. Gray’s tenure at FDA, he was instrumental in leading the development of FDA guidance on diagnostic devices, Bayesian clinical trials and adaptive clinical trials.
Debe Deck is a regulatory affairs professional specializing in both FDA and international registrations. Over the last 23 years, in positions at Chiron Vision and as part of ClinReg Consulting Services, Debe has gained worldwide approvals for a wide range of medical devices through registrations in the US, EU, Canada, Australia, Latin America, South Africa, and Pacific Rim countries. She has served as regulatory project manager for multiple novel Class 3 technologies, preparing overall project plans and submissions, including original IDEs and PMAs. Debe has extensive experience in IDEs, 510(k)s and PMAs for capital equipment (lasers) and permanent implants.
Maureen Johnson, RN is a research nurse and medical writer with a unique combination of expertise in regulatory submissions, regulatory compliance, and postmarket surveillance. With over 25 years of regulatory experience, Maureen has prepared IDEs, 510(k)s, and PMAs and has written various supporting documents including: literature reviews, protocols, adverse event summaries, clinical study reports, directions for use, patient brochures, operator’s manuals, benefit / risk analyses, device descriptions, publications, promotional materials, informed consent documents, and case report forms. In the postmarket surveillance area, Maureen has extensive experience in global adverse event reporting and complaint management where she has been instrumental in setting up electronic MDR (eMDR) reporting systems, setting up customer feedback systems, preparing standard operating procedures, writing MDR position papers, and training companies on postmarket requirements. In the regulatory compliance area, her experience includes clinical inputs for hazard analyses, CAPAs, health hazard evaluations / health risk assessments, and supporting recalls/field corrections.
Greg Spooner, PhD is a physicist by training and has 25+ years developing medical lasers, medical devices, and photonics instrumentation. Dr. Spooner has held director-level positions in R&D departments at early stage medical laser companies and led several successful new product introductions for dermatologic and ophthalmic surgical laser products. At ClinReg Consulting Services, Dr. Spooner has provided scientific analyses, performed technical writing services and participated in meetings with FDA as part of many successful regulatory submissions for Class II and Class III ophthalmic laser devices, including IDEs, 510(k)s and PMAs. Dr. Spooner also has conducted pre-clinical device performance testing services and produced optical radiation safety analyses for ClinReg clients in support of regulatory submissions for photonics and laser based medical devices.
Eeke Romo, DSc. is a Dutch-trained physician with extensive experience in design and conduct of experimental research studies in an academic environment as well as clinical trials in support of product registration. Dr. Romo has more than 25 years of experience in industry at Baxter Healthcare, Edwards Division, Theracardia, a venture-backed private company, and numerous other companies in the capacity of a Clinical Research Consultant and Medical Writer. Dr. Romo’s skills and expertise include preparation of clinical, pre-clinical, annual and interim reports for PMA, IDE and IND submissions; development of protocols, CRFs, manuals, training material for devices, pharmaceuticals, biologics and drug studies; extensive literature reviews for regulatory submissions; preparation of manuscripts for submission to peer-reviewed journals; and management of clinical trial execution. She has prepared final clinical reports for at least 8 original PMA submissions.
Tonya Porter, MS has over 10 years of experience in the medical device industry. Prior to consulting, Ms. Porter was Vice President of Global Regulatory Affairs & Quality Assurance at ReVision Optics, Inc. (RVO), where she was responsible for US product approvals, international product registrations, and assuring the highest quality of products were provided to the RVO customer. Ms. Porter was a member of the RVO team since 2006 and has a diverse background from product development to managing international clinical trials. Prior to joining RVO, she served at FDA in the Division of Chemistry and Material Science (FDA/CDRH/OSEL/DCMS). Ms. Porter has experience in IDEs, PMAs, and PAS for permanent implants.
Steven Kair, M.A. has over 35 years of experience in the medical device industry. Mr. Kair has been a regulatory consultant to the medical device industry since 1994, specializing in regulatory strategy and submissions, clinical research, and Quality Management System (QMS) requirements. Mr. Kair’s experience and expertise focus on the pre-production product development cycle, assisting companies in planning their product development activities to address regulatory and quality requirements, and generate appropriate documentation for regulatory submissions and review by third party auditors. As a consultant he has compiled numerous FDA-related documents for a wide variety of devices. In addition to regulatory submissions, Mr. Kair has extensive experience conducting clinical audits in conformance with the Good Clinical Practices requirements of the International Conference on Harmonization and ISO 14155, and QMS audits in accordance with applicable QMS regulations and standards. Mr. Kair has recently been instrumental in assisting companies adapt their QMS to the new requirements of ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP). He also provides consulting services to clients in order to meet the requirements of the new EU Medical Devices Regulation.
Helene Spencer has over thirty years experience in regulatory affairs and quality assurance, specializing in medical device start-up companies bringing innovative technology to the market in the US and Europe. She has served on the management boards of start-up companies, of which four were acquired and one became a public entity. Her experience includes Class II and Class III medical device approvals, and designing and implementing quality systems in compliance with FDA and international regulations. Helene’s regulatory and quality assurance experience includes medical devices in a variety of clinical applications including urology, interventional neuroradiology, interventional cardiology, critical care medicine, neonatology, anesthesia, and ophthalmology.
Gretchen Neumann has over 20 years of experience in the medical industry managing clinical trials and has been with ClinReg Consulting since 2003. Over the course of her career, Ms. Neumann has managed all aspects of multicenter clinical trials and has managed numerous clinical projects, through development of protocols, informed consent documents, Investigational Review Board (IRB) and Ethics Committee applications, and subsequent interactions with FDA. Ms. Neumann has conducted clinical start-up training, investigator training, clinical report writing, drafting original IDE applications, IDE supplements and IDE annual reports. Ms. Neumann also has extensive experience in conducting clinical audits in conformance with Good Clinical practice and monitoring of clinical trials for Class III significant risk devices to verify conformance with 21 CFR Parts 50, 54, 56, 812 and GCP.
Amanda Culver is the Document Manager for ClinReg Consulting Services, Inc., and is a critical part of the organization with over 8 years of experience. She handles all aspects of the organization and production/publishing of FDA submissions including IDEs, PMAs, INDs (preparation for IND electronic submissions (eCTD), 510(k)s, meeting requests and meeting packages, and annual reports. She is also available to assist clients with small business qualifications, payment to FDA for submission review, data entry for clinical studies, organization of DSMB meetings, SAE reports, FDA panel preparation, meeting logistics, and communications with FDA.
Scott K. Chang, Software and Validation Engineer Scott has worked in the technical sciences since 2006. He is familiar with clinical database management system, such as Clintrial, and the components that support the clinical system (ie. Oracle, Microsoft SQL Server). Scott has validated and verified newly developed systems that is necessary to meet FDA's 21CFR Part 11 requirements. He has also operated diverse computer systems and continues to be an integral part of ClinReg's diverse team.